None listed
Conditions
Interventions
Drug : 1. Phase 1 Clinical Study
1) Investigational product: MRC101 (study drug), placebo (comparator)
2) Route of administration: Subcutaneous administration
3) Method of administration:
? Cohort 1
Sponsors
Verni Aesthetics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria: 1) Adults aged = 19 years to = 65 years as of the date of written consent 2) Individuals who satisfy all of the following: ? Individuals with physician-assisted submental fat rating scale (PA-SMFRS) grade of 2 (moderate) or 3 (severe) as assessed by an independent on-site assessor ? Individuals with patient-reported submental fat rating scale (PR-SMFRS) grade of 2 or 3 ? Individuals with subject self-rating scale (SSRS) grade of 2 or lower by their own assessment of submental fat, i.e., extreme dissatisfaction, dissatisfaction, or slight dissatisfaction 3) Individuals who have been maintaining stable weight for the past 6 months (weight change within ± 10% of their own body weight), and who have agreed to maintain their lifestyle prior to participating in the clinical study such as exercise and diet for the duration of the clinical study 4) Individuals with a body mass index (BMI) of 35 kg/m^2 or lower at screening 5) Individuals who voluntarily provide written consent after sufficiently listening to an explanation of this clinical study and understanding it
Exclusion criteria
Exclusion criteria: Individuals who meet any of the following criteria are not eligible to participate in this study: 1) Individuals who have a history of cosmetic surgery (tissue transplantation, liposuction, etc.) or a history of treatment with lipolytic agents (including DC) that can affect the investigation of therapeutic efficacy of the investigational product on the administration site 2) Individuals who currently have dysphagia or a history thereof 3) Individuals who have diseases related to hypertrophy of the administration site of the investigational product such as thyroid hyperplasia and cervical lymphadenopathy 4) Individuals with excessive skin laxity, platysma bands, or other conditions that may result in cosmetically undesirable outcomes when submental fat is reduced 5) Individuals who have or have a history of significant psychiatric disorders (depression, schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, hyperphagia, etc.) that can affect their compliance with the clinical study procedures according to the judgment of the investigator 6) Individuals who have symptoms of facial nerve paralysis or a history thereof 7) Individuals whose laboratory test results at screening meet the following: - ALT, AST = 2.5 times the upper limit of normal - Serum total protein level = 5.5 g/dl 8) Individuals who show clinically significant disorders in the respiratory system, cardiovascular system, digestive system, endocrine system, and central nervous system that can affect the investigation of safety and therapeutic efficacy in the clinical study: Patients with uncontrolled diabetes mellitus (HbA1c = 7.0%) or patients with uncontrolled hypertension (SBP > 160 mmHg or DBP > 100 mmHg) despite the use of hypoglycemic or antihypertensive drugs within 12 weeks at the time of screening 9) Individuals who are receiving immunosuppressant drugs or have immunodeficiency (HIV-positive, etc.) or autoimmune diseases (rheumatoid arthritis, interstitial lung disease, etc.) 10) Individuals who are receiving anticoagulants (warfarin, etc.) or antiplatelet drugs (clopidogrel, etc.) 11) Individuals who have taken drugs or health supplement foods (appetite stimulants and suppressants, oral steroids, thyroid hormones, statins, etc.) that affect body weight and lipid metabolism within 12 weeks at the time of screening 12) Individuals who have a history of hypersensitivity reactions to the medical devices used in this clinical study (sterilized oil-based pens, administration site design grid pads, injection needles, etc.) 13) Individuals who have hypersensitivity reactions to the components of the investigational product, bovine protein or local anesthetics (lidocaine, etc.), or a history of hypersensitivity reactions such as anaphylaxis 14) Individuals who have inflammation, wounds, swelling caused by bites or stings, or areas with infection or cancer (or their surrounding tissues) at the site where the investigational product is to be administered and at adjacent sites 15) Individuals with a history of head and neck surgery 16) Pregnant women and breastfeeding women, or women of childbearing potential who plan to become pregnant or are unwilling to use adequate contraception* during the clinical study, and men who plan to impregnate their partner or are unwilling to use adequate contraception during the clinical study *Hormonal contraceptives, intrauterine devices, barrier contraception (for males or females) along with spermicide, surgical sterilization proce
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (Phase 1) Identification of DLT and MTD;(Phase 2a) Incidence of adverse events of special interest (nerve damage, ulceration and necrosis at the administration site of the investigational product) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events, Laboratory Tests, Vital Signs, Physical Examination.;(phase 2a) Physician-Assisted Submental Fat Rating Scale;(phase 2a) Patient Reported-Submental Fat Rating Scale ;(phase 2a) Patient Reported-Submental Fat Impact Scale;(phase 2a) Subject Self-Rating Scale;(Phase 2a) Changes in fat volume at the administration site confirmed by MRI;(Phase 2a) Incidence of local adverse events (edema, hardening, pain, hematoma, warm sensation, nodules, erythema, pruritus, bruising) at the administration site of the investigational product | — |
Countries
Korea, Republic of
Contacts
Public ContactBeomjoon Kim
Chung-Ang Univerisity Hospital
Outcome results
None listed